GRAS Status Verification and Affirmation Support Services
Ensuring GRAS compliance in line with 21 CFR Part 170, your path to safe and lawful market entry
To verify and formally affirm that a substance used in a product is generally recognized as safe (GRAS) under the intended conditions of use, in alignment with FDA regulatory standards, without submitting a voluntary GRAS Notification to the FDA.
Scope of Work
The Company will perform third-party verification of the ingredient’s GRAS status. Services include:
1. GRAS Status Verification (Basic Verification)
- • Verify ingredient identity and intended use based on the collected information such as specifications, testing, formula use, and safety data.
- • Look up FDA GRAS Notices, SCOGS opinions, CFR listings, and other authoritative sources.
- • Determine if the ingredient description and intended use align with existing GRAS status.
- • Provide a summary with references, notes on any gaps, limitations, or unclear status.
2. GRAS Affirmation Support (Full Review), if applicable
Regulatory Status Verification
- • Review process descriptions to determine if identity, composition, or safety is affected (e.g., hydrolysis, extraction).
Ingredient and Use Review
- • Verify the full ingredient name, source material, and specification sheets.
- • Confirm CAS number, processing method, and chemical structure (if applicable).
- • Assess intended use level and target consumer population.
Manufacturing Process and Purity Verification
- • Review process descriptions to determine if identity, composition, or safety is affected (e.g., hydrolysis, extraction).
- • Evaluate the source and origin to assess potential risks (e.g., marine species for collagen).
- • Assess for potential contaminants or adulteration risks based on process and origin.
Regulatory and Scientific Literature Evaluation
- • Review ingredient description and intended use for current regulatory status (GRAS-listed, DSHEA-compliant, or NDI-subjected).
- • Conduct scientific literature search for toxicological, clinical, or consumption data to confirm safety under intended use.
- • Evaluate against FDA-established intake limits (e.g., DV, UL, RDI) and determine allergenicity risks where applicable.
- • Check for prior GRAS Notices, EFSA opinions, or other authoritative listings.
Gap Analysis and Risk Identification
- • Identify missing documentation, data gaps, or potential compliance risks that may impact GRAS status affirmation.
GRAS Determination Documentation
- • Draft a GRAS Determination Report that includes:
- ∘ Summary of findings and regulatory conclusions
- ∘ Identified data gaps or further recommendations
- ∘ Supporting references (regulations, scientific studies, or official listings)
Recordkeeping Support
- • Advise on proper retention of GRAS files in case of future FDA inspection or retail inquiry.
Deliverables
• Ingredient Regulatory Status Summary Report (per ingredient)
• List of additional recommendations (if any)
• Reference and bibliography summary (scientific literature, FDA sources)
Fees
Service Option
Description
Investment
Estimated Timeline
GRAS Verification - Entry
Basic check of GRAS status from regulatory sources (1 ingredient)
$99.00
3 to 5 business days
GRAS Verification - Bundle
Basic check of GRAS status from regulatory sources (up to 5 components)
$490.00
7 to 10 business days
GRAS Verification - Novel
Basic check of GRAS status from regulatory sources (up to 10 components)
$975.00
up to 15 business days
GRAS Verification - Pro
Basic check of GRAS status from regulatory sources (up to 25 components)
$2,450.00
up to 25 business days
GRAS Verification - Flagship
Basic check of GRAS status from regulatory sources (up to 50 components)
$4,900.00
up to 45 business days
Full GRAS Affirmation Support
Full affirmation evaluation with complete documentation review for ingredients not listed as GRAS
$750 per ingredient
10 to 25 business days
| Service Option | Description | Investment | Estimated Timeline |
|---|---|---|---|
| GRAS Verification - Entry | Basic check of GRAS status from regulatory sources (1 ingredient) | $99.00 | 3 to 5 business days |
| GRAS Verification - Bundle | Basic check of GRAS status from regulatory sources (up to 5 components) | $490.00 | 7 to 10 business days |
| GRAS Verification - Novel | Basic check of GRAS status from regulatory sources (up to 10 components) | $975.00 | up to 15 business days |
| GRAS Verification - Pro | Basic check of GRAS status from regulatory sources (up to 25 components) | $2,450.00 | up to 25 business days |
| GRAS Verification - Flagship | Basic check of GRAS status from regulatory sources (up to 50 components) | $4,900.00 | up to 45 business days |
| Full GRAS Affirmation Support | Full affirmation evaluation with complete documentation review for ingredients not listed as GRAS | $750 per ingredient | 10 to 25 business days |
Disclaimer
Services provide assessment based on the available documentation to facilitate compliance per applicable regulations, but does not constitute assured regulatory approval, nor does it guarantee market acceptance, regulatory clearance, or product sales in the target market.